Cerebrolysin hydrolysate injection and preparation method thereof

A technology of cerebroprotein hydrolyzate and injection, which is applied in the field of cerebroprotein hydrolyzate injection and its preparation, can solve problems such as anaphylactic shock, and achieve the effect of reducing the degree of allergic reaction

Inactive Publication Date: 2015-03-18

CHENGDU LIST PHARMA

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AI-Extracted Technical Summary

Problems solved by technology

[0003] has been widely used in the treatment of dementia, cerebrovascular disease and ischemic encephalopathy since it was launched in the 1990s. It is an economical, safe, small adverse reaction, It is a highly effective brain cell energizing agent, but cerebroprotein hydrolyzate injection can also cause anaphylactic shock. Aller...

Abstract

The invention discloses a cerebrolysin hydrolysate injection and a preparation method thereof. The preparation method of the cerebrolysin hydrolysate injection comprises the following steps: (1) preparing a fresh and healthy pig brain, removing adipose tissues, homogenizing, vacuumizing at 8Pa, maintaining the pressure for 10 minutes, introducing CO2 until the pressure is 15Pa, and maintaining the pressure for 20 minutes; (2) slowly adding the defatted brains obtained in the step (1) into liquid CO2 in an amount which is 7 times of that of the defatted brains, stirring for 50 minutes, cooling down to the temperate being from -70 to -80 DEG C, keeping for 3 hours, and then increasing the temperature to 45 DEG C within 8 minutes to gasify CO2; (3) adding water for injection in an amount which is 3 times of that of the frozen-thawed brains obtained in the step (2), uniformly stirring, further adding papain or pepsin of which the weigh is equivalent to 0.7% of the weight of the frozen brains, and carrying out hydrolysis at 37 DEG C for 3.5 hours to obtain an enzymatic hydrolysate; and (4) centrifuging the enzymatic hydrolysate, taking a supernatant liquid, adding 1%-10% of HS-15, carrying out activated carbon adsorption at the room temperature, carrying out decarbonization and filtering, regulating the pH value, and filtering after an intermediate is examined to be qualified, so as to obtain the cerebrolysin hydrolysate injection. By virtue of a brand new prescription and process, the prescription safety of the cerebrolysin hydrolysate injection is obviously improved.

Application Domain

Nervous disorderHydrolysed protein ingredients +2

Technology Topic

Activated carbonProteolysis +9

Examples

Experimental program(3)

Example Embodiment

[0011] Example 1 Preparation method of cerebroprotein hydrolysate injection: ①Take healthy fresh pig brain, remove fat, homogenize, vacuumize to 8Pa, vacuum, maintain pressure for 10min, and then pass CO 2 Until the pressure is 15Pa, keep the pressure for 20min; ②At 400rpm, slowly add the brain plasma in ① to 7 times the liquid CO 2 After adding, stir for 50min, lower the temperature to -75℃, keep it for 3 hours, and then raise the temperature to 45℃ within 8min, and remove the CO 2 Gasification; ③Add 3 times the weight of water for injection to step ②, stir evenly, then add papain or pepsin equivalent to 0.7% of the weight of the frozen brain pulp, and hydrolyze it at 37°C for 3.5 hours to obtain the enzymatic hydrolysate; ④ Centrifuge the enzymatic hydrolysate at 2500 rpm for 25 min, take the supernatant, take 100 ml of the supernatant, which contains 6 g of total nitrogen (refer to the WS1-X-018-2001Z quality standard to detect total nitrogen), add 10 ml of HS-15, Activated carbon adsorption at room temperature, decarburization, filtration, add 600ml of water for injection, adjust the PH value to 7.2 with 6mol/L sodium hydroxide solution, make up the water for injection to the full amount of 1000ml, after the clarity is checked, use bipolar 0.22μm micropores It is filtered by membrane.

Example Embodiment

[0012] Example 2 Preparation method of cerebroprotein hydrolysate injection: ①Take healthy fresh pig brain, remove fat, homogenize, vacuumize to 8Pa, vacuum, maintain pressure for 10min, and then pass CO 2 Until the pressure is 15Pa, keep the pressure for 20min; ②At 400rpm, slowly add the brain plasma in ① to 7 times the liquid CO 2 After adding, stir for 50min, lower the temperature to -75℃, keep it for 3 hours, and then raise the temperature to 45℃ within 8min, and remove the CO 2 Gasification; ③Add 3 times the weight of water for injection to step ②, stir evenly, then add papain or pepsin equivalent to 0.7% of the weight of the frozen brain pulp, and hydrolyze it at 37°C for 3.5 hours to obtain the enzymatic hydrolysate; ④ Centrifuge the enzymatic hydrolysate at 2500 rpm for 25 minutes, take the supernatant, take 100ml of the supernatant, which contains 6g of total nitrogen (refer to the WS1-X-018-2001Z quality standard to detect total nitrogen), add 50ml of HS-15, Activated carbon adsorption at room temperature, decarburization, filtration, add 650ml of water for injection, adjust the PH value to 7.3 with 6mol/L sodium hydroxide solution, make up the water for injection to the full amount of 1000ml, after the clarity is checked, use bipolar 0.22μm micropores It is filtered by membrane.

Example Embodiment

[0013] Example 3 Preparation method of cerebroprotein hydrolysate injection: ①Take healthy fresh pig brain, remove fat, homogenize, vacuumize to 8Pa, vacuum, maintain pressure for 10min, and then pass CO 2 Until the pressure is 15Pa, keep the pressure for 20min; ②At 400rpm, slowly add the brain plasma in ① to 7 times the liquid CO 2 After adding, stir for 50min, lower the temperature to -75℃, keep it for 3 hours, and then raise the temperature to 45℃ within 8min, and remove the CO 2 Gasification; ③Add 3 times the weight of water for injection to step ②, stir evenly, then add papain or pepsin equivalent to 0.7% of the weight of the frozen brain pulp, and hydrolyze it at 37°C for 3.5 hours to obtain the enzymatic hydrolysate; ④ Centrifuge the enzymatic hydrolysate at 2500 rpm for 25 minutes, take the supernatant, take 100ml of the supernatant, which contains 6g of total nitrogen (refer to the WS1-X-018-2001Z quality standard to detect total nitrogen), add 100ml of HS-15, Activated carbon adsorption at room temperature, decarburization, filtration, add 700ml of water for injection, adjust the PH value to 7.4 with 6mol/L sodium hydroxide solution, make up the water for injection to the full amount of 1000ml, after the clarity is checked, use bipolar 0.22μm micropores It is filtered by membrane.

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Description & Claims & Application Information

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